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OtoSurg 1: Global Pediatric Tonsillectomy Study

Building a de-identified database to perform an international prospective evaluation of tonsillectomy indications, techniques, and outcomes.

Mission

OtoSurg is a global prospective, multi-site, de-identified, observational study aimed at establishing a global data registry of pediatric tonsillectomy indications, techniques, and outcomes. OtoSurg, partnered with the Global OHNS Initiative, will build, recruit, and train a collaborative research network of OHNS surgeons and trainees worldwide. By working together, we aspire to develop a robust and sustainable digital infrastructure that is well-equipped to drive future research projects.

This figure illustrates the logistical framework of the OtoSurg 1 hub-and-spoke model. The Global OHNS Initiative and Emory University will serve as the central hub (shown in blue) and the institutions through which the primary IRB and REDCap databases are housed. The first series of spokes connect the central hub to the primary nodes (shown in orange) which will consist of the 6 WHO regions. Each of these regions will have two regional leads who will serve as liaisons between their associated partner institutions and the central hub. The second series of spokes connect the primary nodes to the secondary nodes (shown in green) which consist of individual countries within the WHO regions. Within each country, individual institutions will elect one member of their respective research teams to serve as the institutional liaison to the regional representatives. This multi-tiered leadership structure will empower local sites to apply contextually appropriate strategies for data collection with a region-specific liaison available for assistance. All teams will be overseen through the central hub where centralized resources will be made available to all partner sites.

Project Information

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Methods

Project Significance

This figure provides a visual representation of the OtoSurg 1 team structure. The principal investigators of OtoSurg1 are Drs. Zachary Elwell, Taseer Din, and Maxwell Kligerman. Dr. Katie Shaw of GlobalSurg has graciously provided us with feedback and guidance regarding the overarching principles of research planning for a large scale, international, prospective study. The OtoSurg Team is further divided into three core teams: the data management team (led by Max), the research support team (led by Zachary), and the recruitment team (led by Taseer). The recruitment team oversees the WHO regional leads, individual country leads, and specific hospital teams. Each hospital team is composed of a team lead, data collector, and data validator. The research support team oversees the onboarding process for new OtoSurg members, develops educational materials, training modules, and the internal and external-facing protocols. Additionally, this team oversees website design and management in partnership with the Global OHNS and provides IRB and REDcap support. The recruitment team and research support teams work together closely at the hospital team level to ensure that each team has the support they need to successfully collect and upload data to the REDCap database. The data management team is responsible for the collection, validation, management, and analysis of all study data in a secure, de-identified database. Additionally, the data management team obtained the principal IRB approval through Emory University that will be used for all subsequent partner site IRB applications. Finally, this team is responsible for developing the data sharing agreement and data dictionary to be used by all partner sites. By working closely together, the three core teams are the heart of OtoSurg1.

Partner Site Requirements

  • Any healthcare setting worldwide where pediatric tonsillectomies are performed will be eligible to participate.* 

  • Each participating site will develop a research team with two to four investigators.

  • Each team will have one representative who will liaise with the central hub.

  • There is no minimum number of patients per site, and no limit to the number of sites within a World Health Organization region or country.

  • All contributors will be eligible for authorship.​

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*China is not eligible for participation due to the Personal Information Protection Law of the People’s Republic of China (PIPL)

Resources for Partner Sites

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